FDA.reportPublic FDA data

MAUDE MDR 9908767

MDR report key
9908767
Report number
1219930-2020-01470
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA HERNANDEZ
Address
60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN ENDO GIA SULUSTAPLE, IMPLANTABLECOVIDIEN LP LLC NORTH HAVENGDWUNKNOWN ENDO GIA SULUUNKNOWN ENDO GIA SULU* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ACCORDING TO THE REPORTER, DURING KIDNEY TRANSPLANT, THE SURGEONS ATTEMPTED TO FIRE THE DEVICE BUT THREE RELOADS MISFIRED. STAPLER WAS ABLE TO BE RELEASED FROM THE KIDNEY WITHOUT DAMAGING IT. ANOTHER STAPLER WAS USED WITH TWO OTHER LOADS SUCCESSFULLY. THERE WAS NO PATIENT INJURY.